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CTRI Number  CTRI/2025/02/081027 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effectiveness of oral antioxidant supplements in patients with gum disease 
Scientific Title of Study   Evaluation and Comparison of Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus MucofibroTM V/S Scaling and Root Planing alone: A one month Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Saurabh Prithyani 
Designation  Reader 
Affiliation  Terna Dental College 
Address  101, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706

Thane
MAHARASHTRA
400706
India 
Phone  07208020305  
Fax    
Email  saurabh.prithyani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rhea Vivek Kashid 
Designation  Post graduate student 
Affiliation  Terna Dental College 
Address  101, Department of Periodontolgy, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706

Thane
MAHARASHTRA
400706
India 
Phone  08097907825  
Fax    
Email  rheavkashid25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Sanika Girish Patil 
Designation  Post graduate student 
Affiliation  Terna Dental College 
Address  101, Department of Periodontology, Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai.

Thane
MAHARASHTRA
400706
India 
Phone  07420830981  
Fax    
Email  drsanika99@gmail.com  
 
Source of Monetary or Material Support  
TPCTs Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706 
 
Primary Sponsor  
Name  TPCTs Terna Dental College 
Address  Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai. Maharashtra (India) Pin – 400706 
Type of Sponsor  Other [Private Dental College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sanika Patil  Terna Dental College  Terna Dental College Plot No. 12, Sector- 22, Nerul (W), Navi Mumbai.
Thane
MAHARASHTRA 		 07420830981

drsanika99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy patients undergoing non-surgical periodontal therapy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral anti-oxidant supplement along with Scaling and Root planing  Patients undergoing non-surgical periodontal treatment, with a tobacco habit will be treated with scaling and root planing and given oral anti-oxidant supplements twice daily for 15 days. Baseline evaluation will be done for Plaque index, gingival index, oral hygiene-simplified index and modified sulcular bleeding index. Patient will be recalled after 15 days for evaluation of the same. 
Comparator Agent  Scaling and Root planing  Patients undergoing non-surgical periodontal treatment, with a tobacco habit will be treated with scaling and root planing for 15 days. Baseline evaluation will be done for Plaque index, gingival index, oral hygiene-simplified index and modified sulcular bleeding index. Patient will be recalled after 15 days for evaluation of the same. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients free from systemic diseases between the age group of 18-70 years, who signed the consent form, having a habit of tobacco consumption and undergoing non-surgical periodontal therapy were a part of this clinical trial.  
 
ExclusionCriteria 
Details  Patients giving a history of undergoing surgical periodontal treatment in the past 6 months, as well as pregnant or lactating women, were excluded from the study. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the efficacy of oral antioxidant supplement as an adjunt to scaling and root planing in the non-surgical management of Periodontal Disease in Tobacco Users

2. To evaluate the efficacy of scaling and root planing in the non-surgical management of Periodontal Disease in Tobacco Users

3. To compare the efficacy of oral antioxidant supplement as an adjunt to scaling and root planing versus scaling and root planing alone in the non-surgical management of Periodontal Disease in Tobacco Users

 		 Baseline and after 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
The clinical parameters evaluated were- Oral Hygiene Index- Simplified(OHI-S), Plaque Index(PI), Gingival Index(GI), Modified Sulcular Bleeding Index (M-SBI), Pocket probing depth (PPD) and Clinical Attachment Level (CAL).   Baseline and after 15 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   01/04/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="0"
Days="15" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

AIM- To evaluate and compare the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus MucofibroTM V/S Scaling and Root Planing alone.

OBJECTIVES- 

1.      To evaluate the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus oral antioxidant supplement.

2.      To evaluate the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing alone.

3.      To compare the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus oral antioxidant supplement V/S Scaling and Root Planing alone.


The study will evaluate the following parameters- Oral Hygiene Index Simplified, Plaque index, Gingival index, Clinical Attachment level, Pocket probing depth. 

These parameters will be evaluated at baseline and after 15 days. Based on the results obtained it will be evaluated whether the use of oral antioxidant supplements can provide any additional benefit in improvement in clinical parameters in tobacco users.
 
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